Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011562129

FEI Number

3011562129

Entity Name

MIRAE MEDI&TECH CO., LTD.

City/State/Country

Cheonan-si Chungnam, KR

Establishment Address

22, Baekseokgongdan 5-gil, Seobuk-gu, Cheonan-si Chungnam 331-979, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MIRAE Medi&Tech Co., Ltd. (Owner Number: 10049046)

Owner / Operator Contact Address

22, Baekseokgongdan 5-gil, Seobuk-gu, Cheonan-si, KR-44 331-979, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

REVITIVE CIRCULATION BOOSTER STIMULATOR MUSCLE POWERED FOR MUSCLE CONDITIONING STIMULATOR NERVE TRANSCUTANEOUS OVER THE COUNTER STIMULATOR MUSCLE POWERED STIMULATOR ELECTRICAL TRANSCUTANEOUS FOR ARTHRITIS REVITIVE MEDIC STIMULATOR NERVE TRANSCUTANEOUS FOR PAIN RELIEF STIMULATOR MUSCLE POWERED FOR MUSCLE CONDITIONING STIMULTATOR NERVE TRANSCUTANEOUS OVER THE COUNTER STIMULATOR MUSCLE POWERED STIMULATOR ELECTRICAL TRANSCUTANEOUS FOR ARTHRITIS STIMULATOR MUSCLE POWERED FOR MUSCLE CONDITIONING SITIMULATOR NERVE TRANSCUTANEOUS OVER THE COUNTER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2015-04-07
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2015-04-07
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2020-11-23
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2020-11-23
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2020-11-23
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2020-11-23
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2015-04-07
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2021-12-20
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2021-12-20
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2021-12-20
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2021-12-20
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2021-12-20
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2020-11-23
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2020-11-23

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

MIRAE Medi&Tech Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03
K820884	Nitron Electronics	ELECTRICAL MUSCLE STIMULATOR	1982-04-29
K201958	Therasigma, LLC	ETD Family of Electrotherapy Devices	2020-08-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011562129. Last updated year: 2026. Please use registration number 3011562129 when referencing this establishment in official correspondence.